1. Field of the Invention
The present disclosure relates to a formix manipulator, and more particularly, to a device that delineates and deviates the vaginal formix while preserving access to the cervix and supporting the vaginal wall to create a platform or plane for dissection.
2. Description of the Related Art
In some medical procedures, the vaginal formix may need to be delineated and/or deviated away from other vital organs. In addition, the formix and neighboring vaginal wall may need to be supported to provide a platform or plane for dissection. Many medical procedures require manipulation of the formix. These include but are not limited to: hysterectomies; colpotomies; vaginal suspensions; colpoplexies; and resections of vesicovaginal fistulas, pelvic endometriesis, cancer, fibroids, and adhesions.
For example, in a hysterectomy, a surgeon cuts through the vaginal formix to detach and remove the cervix and uterus from the body. Here, the vaginal formix must be precisely delineated to prevent injury to the vaginal wall and neighboring vital organs, such as the bladder, bowel, or ureters. In addition to delineating the formix, the surgeon may also have to deviate or move the formix away from vital organs during incision. If organs are connected to the vaginal wall or formix, the surgeon may also have to dissect or cut the connecting tissue. This requires supporting the formix and vaginal wall together to provide an adequate platform or plane for dissection.
FIG. 1A-C illustrate the location of the formix. FIG. 1A is a sagittal cross-section of a female pelvis. The cervix 103 opens into the uterus 104, and the ovaries 105 are connected to the uterus 104. On one side of the vagina 107, toward the front of the body, is a bladder 112 and a urethra 106 leading from the bladder to an outside of the body. On another side of the vagina 107, toward the rear of the body, is the rectum 109 between intestines 110 and the anus 108 which opens from the rectum 109 to outside the body.
FIG. 1B is a view of the cervix 103 from the vaginal canal. FIG. 10 is a simplified view of the uterus 104 from within the abdomen 111. Surgeons may access the uterus 104 and other organs from the abdominal cavity 111.
The formix 100 is a cylindrical ring of tissue encircling the cervix 103 and lower uterus 104. The lowest cylindrical ring is the intra-vaginal formix 101, The intra-vaginal formix 101 encircles the cervix 103 and is visible from the vaginal canal, as illustrated by FIG. 1B. The intra-vaginal formix 101 is located between the vaginal wall 102 and the cervix 103, as illustrated by FIGS. 1A and 1B.
The upper-most cylindrical ring of the fornix 100 is the intra-abdominal fornix 113. When viewed from the abdomen, as in FIG. 1C, the anterior half of the intra-abdominal fornix 113 may be visible, but it is neither demarcated nor obvious to the human eye. It is therefore indicated with a dotted line. The ring of the intra-abdominal fornix 113 passes between the uterus 104 and rectum 109, and also passes between the uterus 104 and bladder 112, as indicated by FIG. 1.
The length of the formix 100, or the distance between the lowest and upper-most cylindrical rings (i.e. the intra-vaginal formix 101 and intra-abdominal formix 113, respectively) is indicated by dotted lines in FIG. 1.
Several problems and injuries may result when using conventional devices, known as uterine manipulators, to manipulate the formix 100. These problems include imprecise formix delineation and deviation; vaginal shortening; and abdominal deflation. Injury can also result from blocked cervical access and blind cervical retrieval; device insertion and retrieval; and lack of a platform while dissecting vital organs away from the formix and vaginal wall.
FIGS. 2A and 2B illustrate a first conventional device to perform uterine manipulation, and FIG. 3 illustrates a second conventional device. In the first conventional device 210, a first cup 211 has a first end 213 positioned at or near the intra-vaginal fornix 101. The second device 310 has a similar shape, with a single cup 311 having a first end 313 positioned at or near the intra-vaginal fornix 101. When pressure is applied against cups 211 or 311, their respective first ends 213 and 313 push the intra-vaginal fornix 101 against the intra-abdominal fornix 113. Eventually, the first end bulges through the fornix 100 into the abdomen as a distended ring of fornix tissue. The bulging ring formed by the first ends delineates the circumference of the fornix 100 when viewed from the abdomen.
Conventional devices may misestimate the location and diameter of the vaginal formix 100, causing inaccurate delineation. The diameter of the first ends 213 and 313 of devices 210 and 310, respectively, may be greater than the diameter of the intra-vaginal formix 101. Here, first ends 213 and 313 do not delineate the intra-vaginal formix 101, but the upper third of the vaginal wall 102. In addition, the length of the cervix may be greater than the depths of the cups 211 and 311, respectively. Here, first ends 213 and 313 would not delineate the intra-vaginal formix 101, since the length of the cervix 103 would prevent the ends 213 and 313 from reaching the intra-vaginal formix 101. Rather, the devices would delineate the upper third of the vaginal wall.
When conventional devices misestimate the location and diameter of the vaginal formix 100, the surgeon cannot precisely deviate the formix away from other vital organs when operating inside the abdomen 111.
Inaccurate delineation can also lead to vaginal shortening. If a surgeon seeks to cut through the circumference of the formix 100, the inaccurate delineation may cause the surgeon to cut through the vaginal wall 102, instead of in the formix 100 itself. When a surgeon cuts the vaginal wall instead of the formix 100, the length of the vaginal canal decreases.
Conventional uterine manipulators are also ill-suited for laparascopic and robotic surgeries that require abdominal inflation, also known as inflation of the peritoneal cavity. In laparoscopic and robotic surgeries, a camera and surgical tools are inserted through a navel port or small incisions on the lower abdomen. A constant supply of air or gas is pumped into the abdomen to inflate the abdomen. The inflated abdomen creates space for the surgeon to maneuver the camera and instruments without injuring vital organs. However, when a surgeon makes an incision through the vaginal formix, gas escapes from the abdomen through the vaginal canal. When the air leaks out, the abdomen disinflates, making it difficult to maneuver instruments and increasing the risk of organ injury.
Conventional uterine manipulators do not prevent abdominal disinflation. Rather, incised tissue retracts from the point of the incision and creates a hole or space between the device and tissue for air to escape. In the first device 210, since the first end 213 of the first cup 211 has a diameter greater than the second end 214, the tissue of the vaginal wall 102 retracts from the incision at the first end 213 toward the second end 214. A space forms between the vaginal wall 102 and first device 210. Consequently, air escapes from the abdominal cavity 111. The second device 310 attempts to prevent air leakage by inflating a balloon 312 within the vagina 107. However, air may continue to leak, and at the same time, the cervix 103 cannot be accessed from the vagina 107.
Conventional uterine manipulators block access to the cervix from the vagina 107. For example, the first device 210 blocks access to the cervix 103 with both the first and second cups 211 and 212, and the second device 310 blocks access to the cervix 103 with the balloon 312. Consequently, if the cervix 103 and attached uterus 104 must be retrieved from the vagina 107 after a hysterectomy, the surgeon must first remove the uterine manipulator and then reach into the vagina 107 to blindly feel around for the cervix 103. At times, the surgeon pulls and tears the incised formix 100 or vaginal wall 102. In robotic operations in particular, this may add significant time to the procedure, since it requires the surgeon to scrub before reaching in.
Conventional uterine manipulators pose injury risks in removal. For example, the cups 211, 212, and 311 may get stuck in the vaginal canal when the uterine manipulator 230 or 330 is extracted from the vagina 107. This may occur since the diameter of the cups may be larger than a diameter of the vaginal opening. To retrieve the cups, the surgeons must blindly reach and fish for the cups. At times, the surgeon may pull and damage tissue, or the surgeon may have cut the vaginal opening to remove the cups.
Conventional uterine manipulators also pose injury risks upon insertion. Since the devices are of predetermined diameters with the first end larger than the second end, the tissue of the vaginal wall 102 may be damaged when the vagina 107 has a smaller diameter than the diameters of the first ends of devices 210 and 310.
Conventional uterine manipulators do not provide a platform or plane for dissection. For example, when performing a hysterectomy, the surgeon may need to dissect vital organs such as the bladder 112 and the rectum 109 away from the vaginal wall. These vital organs are connected to the vaginal wall 102 and at times the formix 100. Thus, heat from cauterizing the formix 100 may travel through the tissue and injure the these organs if not dissected away. In the first device 210, cups 211 and 212 become narrower at their intersection 210, and therefore do not provide a surface or plane on which to perform a dissection. The second device 310 likewise does not provide a surface for dissection since there are spaces or holes in cup 312. The lack of a platform or even plane increases the risk of injury to vital organs in hysterectomies as well as other operations that require resections, such as operations to remove endometriosis, cancer, fibroids, pelvic adhesions, and vesicovaginal fistulas.